S-Equol in Alzheimer's Disease 2 Trial

NCT03101085 | Completed Phase 1 Results FDA Drug

• 1 other identifier: SEAD2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen in the body, causes an increase in mitochondrial activity. Researchers also hope to determine the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences cognition.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity

  Cytochrome oxidase (COX) was measured in platelet mitochondria as a pseudo-first order rate constant (sec-1/mg protein), which was determined as a Vmax, spectrophotometrically, by tracking the change in absorbance as reduced cytochrome c is oxidized to oxidized cytochrome C. Citrate synthase (CS) is a soluble mitochondrial matrix enzyme whose activity was determined spectrophotometrically as a Vmax (micromoles/mg protein). Reporting the COX activity as a ratio to CS activity takes mitochondrial mass into account, and normalizes the COX activity per the amount of mitochondria present in the assay sample, with units 1/(seconds multiplied by micromoles).

  Column 1 is the value after completing S-equol minus the value after completing placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 COX/CS value. For placebo then S-equol, this is the Visit 4 minus the Visit 3 COX/CS value.

Secondary Outcomes (9)

• Pattern of COX Activity Changes While on the Active Treatment Versus Placebo Arms of This Crossover Study.

  Visits 2, 3, 4

• Montreal Cognitive Assessment (MoCA)

  Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 MoCA score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 MoCA score.

• Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11)

  Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 ADASCog score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 ADASCog score.

• Logical Memory Test 1 (LMT1) - Immediate Recall

  Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 LMT1 score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 LMT1 score.

• Logical Memory Test 2 (LMT2) - Delayed Recall

  Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 LMT2 score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 LMT2 score.

Study Arms (2)

S-equol First, Then Placebo

OTHER

In this arm, participants receive S-equol 50mg twice daily for one month, followed by placebo twice daily for one month. There was no washout period.

Drug: S-equol and Placebo

Placebo First, Then S-equol

OTHER

In this arm, participants receive placebo twice daily for one month, followed by S-equol 50mg twice daily for one month. There was no washout period.

Drug: Placebo and S-equol

Interventions

S-equol and Placebo DRUG

S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules. The placebo is a matched pill that cannot be distinguished from the active S-equol.

Also known as: S-equol is also called AUS-131

S-equol First, Then Placebo

Placebo and S-equol DRUG

S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules. The placebo is a matched pill that cannot be distinguished from the active S-equol.

Also known as: S-equol is also called AUS-131

Placebo First, Then S-equol

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of Alzheimer's Disease (AD)
• Have a study partner who has a close relationship with the participant and will attend study visits with the participant
• Do not possess an Alkylphenol ethoxylates 4 (APOE4) variant of the APOE gene
• Speak English as their primary language
• Have not had any medication changes within the past 30 days

You may not qualify if:

• Reside in a nursing home or dementia special care unit
• Have a potentially confounding, serious medical risk such as insulin-requiring diabetes, any history of cancer that required a chemotherapy or radiation therapy intervention within the past 5 years, or a recent cardiac event
• Have any clinically significant abnormal safety laboratory values at the SEAD2 screening visit
• Have any clinically significant abnormal findings on vital signs measurements, or on physical or neurological examination at the SEAD2 screening visit
• Use any type of systemic estrogen or testosterone replacement therapy
• Has participated in another clinical trial or received any investigational drug or investigational therapy within 30 days before the screening visit

Sponsors & Collaborators

• Russell Swerdlow: lead
• Ausio Pharmaceuticals, LLC: collaborator

Study Sites (2)

Clinical and Translational Science Unit

Fairway, Kansas, 66205, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Equol

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Russell Swerdlow
• Organization: University of Kansas Medical Center

rswerdlow@kumc.edu

913-588-0970

Study Officials

• Russell Swerdlow, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: May 5, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: July 25, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)